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NASDAQ:

ALXN

"Alexion delivered strong performance in the second quarter of 2017 while also executing on several initiatives to position the company for the future, including strengthening the Soliris patent portfolio, reaching a funding agreement for Strensiq in England, advancing the late-stage pipeline, enhancing compliance and culture and building a strong leadership team"

NEW HAVEN, Conn.--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial
results for the second quarter of 2017. Total revenues in the quarter
were $912 million, a 21 percent increase compared to the same period in
2016. Second quarter revenue reflected a benefit of approximately $35
million due to favorable timing of orders compared to our prior
forecast. The negative impact of foreign currency on total revenue
year-over-year was 2 percent or $12 million, net of hedging activities.
On a GAAP basis, diluted earnings per share (EPS) in the quarter was
$0.73 per share, compared to $0.53 per share in the second quarter of
2016. Non-GAAP diluted EPS for the second quarter of 2017 was $1.56 per
share, compared to $1.13 per share in the second quarter of 2016.

"Alexion delivered strong performance in the second quarter of 2017
while also executing on several initiatives to position the company for
the future, including strengthening the Soliris patent portfolio,
reaching a funding agreement for Strensiq in England, advancing the
late-stage pipeline, enhancing compliance and culture and building a
strong leadership team," said Ludwig Hantson, Chief Executive Officer of
Alexion. "Our strategy for the next phase of growth will focus on our
strengths to deliver sustainable long-term performance and increased
value for shareholders. We will achieve this by growing our rare disease
business, leveraging our expertise in complement, pursuing disciplined
business development to expand the pipeline, and taking steps to
optimize our infrastructure and operating model."

Strensiq® (asfotase alfa) net product sales were $83
million, compared to $45 million in the second quarter of 2016,
representing an 84 percent increase.

Kanuma® (sebelipase alfa) net product sales were $15
million, compared to $7 million in the second quarter of 2016,
representing a 114 percent increase.

GAAP R&D expense was $199 million, compared to $180 million in the
same quarter last year. Non-GAAP R&D expense was $179 million,
compared to $165 million in the same quarter last year.

GAAP SG&A expense was $265 million, compared to $232 million in the
same quarter last year. Non-GAAP SG&A expense was $227 million,
compared to $200 million in the same quarter last year.

GAAP diluted EPS was $0.73 per share, compared to $0.53 per share in
the same quarter last year. Non-GAAP diluted EPS was $1.56 per share,
compared to $1.13 per share in the second quarter of 2016.

Research and Development

Alexion is redefining the Company’s Research & Development (R&D)
strategy to create greater efficiency and focus on its expertise in
complement biology and core therapeutic areas of hematology, nephrology,
neurology, and metabolic disorders. To optimize and align R&D
investments and development efforts with the Company's redefined
strategy, Alexion is de-prioritizing the ALXN1101 (cPMP replacement
therapy) and ALXN6000 (samalizumab) clinical development programs and
will seek to out-license these assets. Alexion is also discontinuing its
preclinical programs with mRNA therapies as well as other preclinical
programs that are outside of the complement franchise, and is therefore
terminating its partnerships with Moderna Therapeutics, Blueprint
Medicines and Arbutus Biopharma.

Complement Portfolio Updates

Eculizumab- Refractory Generalized Myasthenia Gravis (gMG): Alexion
has submitted applications in the U.S., EU and Japan to extend the
indication for eculizumab as a potential treatment for patients with
refractory gMG who are AChR-positive. Alexion received a positive
opinion from the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) in the second quarter and a
final decision from the European Commission (EC) is anticipated in the
third quarter of 2017. Alexion's application in the U.S. has been
accepted for review by the U.S. Food and Drug Administration (FDA) and
the FDA has set a Prescription Drug User Fee Act (PDUFA) date of
October 23, 2017.

ALXN1210- PNH: Enrollment is complete in a Phase 3 trial
comparing ALXN1210 administered intravenously every eight weeks to
Soliris in complement inhibitor treatment-naive patients with PNH.
Alexion expects to report data from this study in the second quarter
of 2018. Alexion initiated a Phase 3 PNH Switch study of ALXN1210
administered intravenously every eight weeks compared to patients
currently treated with Soliris in the second quarter of 2017. The
Company expects to complete enrollment in this study in the third
quarter of 2017.

ALXN1210- aHUS: Patients are being dosed in a Phase 3 trial
with ALXN1210 administered intravenously every eight weeks in
complement inhibitor treatment-naive adolescent and adult patients
with aHUS. Enrollment is expected to be complete in early 2018.
Alexion expects to initiate a Phase 3 trial of ALXN1210 in pediatric
patients with aHUS in the third quarter of 2017.

ALXN1210- Subcutaneous: Initial pharmacokinetic and
tolerability data from the Phase I study in healthy volunteers support
progressing the development of a subcutaneous formulation of ALXN1210.

2017 Financial Guidance

Alexion is increasing its revenue guidance, narrowing its GAAP EPS
guidance and increasing its non-GAAP EPS guidance. Further guidance
updates are outlined below.

Updated GAAP

Updated Non-GAAP

Prior Non-GAAP

Guidance

Prior GAAP Guidance

Guidance

Guidance

Total revenues

$3,450 to $3,525 million

$3,400 to $3,500 million

$3,450 to $3,525 million

$3,400 to $3,500 million

Soliris revenues

$3,075 to $3,125 million

$3,025 to $3,100 million

$3,075 to $3,125 million

$3,025 to $3,100 million

Metabolic revenues

$375 to $400 million

$375 to $400 million

$375 to $400 million

$375 to $400 million

R&D (% total revenues)

23% to 25%

24% to 26%

21% to 22%

22% to 23%

SG&A (% total revenues)

29% to 30%

28% to 30%

25% to 26%

25% to 26%

Operating margin

23% to 26%

25% to 28%

43% to 44%

43% to 44%

Earnings per share

$2.82 to $3.12

$2.80 to $3.20

$5.40 to $5.55

$5.10 to $5.30

Updated 2017 financial guidance assumes the following:

Foreign currency headwinds of $40 to $50 million versus prior
assumption of $50 to $60 million

Soliris revenue impact of $70 to $100 million from ALXN1210 and other
clinical trial recruitments versus prior assumption of $70 to $110
million

Alexion’s financial guidance is based on current foreign exchange rates
net of hedging activities and does not include the effect of business
combinations, license and collaboration agreements, asset acquisitions,
intangible asset impairments, changes in fair value of contingent
consideration or restructuring activity that may occur after the day
prior to the date of this press release.

Conference Call/Webcast Information:

Alexion will host a conference call/audio webcast to discuss the second
quarter 2017 results, at 10:00 a.m. Eastern Time. To participate in the
call, dial 877-852-6543 (USA) or 719-325-4789 (International), passcode
2566061 shortly before 10:00 a.m. Eastern Time. A replay of the call
will be available for a limited period following the call. The replay
number is 888-203-1112 (USA) or 719-457-0820 (International), passcode
2566061. The audio webcast can be accessed on the Investor page of
Alexion’s website at: http://ir.alexionpharm.com.

About Alexion

Alexion is a global biopharmaceutical company focused on developing and
delivering life-transforming therapies for patients with devastating and
rare disorders. Alexion is the global leader in complement inhibition
and has developed and commercializes the first and only approved
complement inhibitor to treat patients with paroxysmal nocturnal
hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two
life-threatening ultra-rare disorders. In addition, Alexion’s metabolic
franchise includes two highly innovative enzyme replacement therapies
for patients with life-threatening and ultra-rare disorders,
hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D).
Alexion is advancing its rare disease pipeline with highly innovative
product candidates in multiple therapeutic areas. This press release and
further information about Alexion can be found at: www.alexion.com.

[ALXN-E]

This press release contains forward-looking statements, including
statements related to guidance regarding anticipated financial results
for 2017, assessment of the Company's commercialization efforts and
commercial potential for Soliris, Strensiq and Kanuma, medical and
commercial potential of each of Alexion's product candidates, launch
expectations for Strensiq and Kanuma, and plans for regulatory filings
and clinical programs for our product candidate, and anticipated changes
to the Company’s R&D strategy. Forward-looking statements are subject to
factors that may cause Alexion's results and plans to differ from those
expected, including for example, decisions of regulatory authorities
regarding the adequacy of our research, marketing approval or material
limitations on the marketing of our products, delays, interruptions or
failures in the manufacture and supply of our products and our product
candidates, failure to satisfactorily address matters raised by the FDA
and other regulatory agencies, the possibility that results of clinical
trials are not predictive of safety and efficacy results of our products
in broader patient populations, the possibility that current rates of
adoption of Soliris in PNH, aHUS or other diseases are not sustained,
the possibility that clinical trials of our product candidates could be
delayed, the adequacy of our pharmacovigilance and drug safety reporting
processes, the risk that third party payors (including governmental
agencies) will not reimburse or continue to reimburse for the use of our
products at acceptable rates or at all, risks regarding government
investigations, including investigations of Alexion by the U.S.
Securities and Exchange Commission (SEC) and U.S. Department of Justice,
the risk that anticipated regulatory filings are delayed, the risk that
estimates regarding the number of patients with PNH, aHUS, HPP and LAL-D
are inaccurate, the risks of changing foreign exchange rates, and a
variety of other risks set forth from time to time in Alexion's filings
with the SEC, including but not limited to the risks discussed in
Alexion's Quarterly Report on Form 10-Q for the period ended March 31,
2017 and in our other filings with the SEC. Alexion does not intend to
update any of these forward-looking statements to reflect events or
circumstances after the date hereof, except when a duty arises under law.

In addition to financial information prepared in accordance with
GAAP, this press release also contains non-GAAP financial measures that
Alexion believes, when considered together with the GAAP information,
provide investors and management with supplemental information relating
to performance, trends and prospects that promote a more complete
understanding of our operating results and financial position during
different periods. The non-GAAP results exclude the impact of the
following GAAP items: share-based compensation expense, fair value
adjustment of inventory acquired, amortization of purchased intangible
assets, changes in fair value of contingent consideration,
acquisition-related costs, restructuring expenses, upfront and milestone
payments related to licenses and collaborations, impairment of
intangible assets and adjustments to income tax expense. These non-GAAP
financial measures are not intended to be considered in isolation or as
a substitute for, or superior to, the financial measures prepared and
presented in accordance with GAAP and should be reviewed in conjunction
with the relevant GAAP financial measures. Please refer to the attached
Reconciliations of GAAP to non-GAAP Financial Results and GAAP to
non-GAAP 2017 Financial Guidance for explanations of the amounts
adjusted to arrive at non-GAAP net income and non-GAAP earnings per
share amounts for the three and six month periods ended June 30, 2017
and 2016 and projected twelve months ended December 31, 2017.

(Tables Follow)

ALEXION PHARMACEUTICALS, INC.

TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in millions, except per share amounts)

(unaudited)

Three months ended

Six months ended

June 30

June 30

2017

2016

2017

2016

Net product sales

$

912

$

753

$

1,781

$

1,453

Other revenue

—

—

1

1

Total revenues

912

753

1,782

1,454

Cost of sales

84

60

153

119

Operating expenses:

Research and development

199

180

418

356

Selling, general and administrative

265

232

527

465

Amortization of purchased intangible assets

80

80

160

160

Change in fair value of contingent consideration

24

5

28

(10

)

Acquisition-related costs

—

1

—

2

Restructuring expenses

3

—

27

1

Impairment of intangible assets

31

—

31

—

Total operating expenses

602

498

1,191

974

Operating income

226

195

438

361

Other income and expense:

Investment income

4

2

8

3

Interest expense

(24

)

(24

)

(48

)

(48

)

Other income (expense)

—

(3

)

2

(3

)

Income before income taxes

206

170

400

313

Income tax expense (1)

41

50

65

101

Net income

$

165

$

120

$

335

$

212

Earnings per common share

Basic

$

0.74

$

0.54

$

1.49

$

0.94

Diluted

$

0.73

$

0.53

$

1.49

$

0.94

Shares used in computing earnings per common share

Basic

224

224

225

225

Diluted

225

226

225

226

(1)

In March 2016, the FASB issued a new standard intended to simplify
certain aspects of the accounting for employee share-based payments.
We elected to early adopt this standard in the third quarter of
2016. The standard requires restatement of previously reported
results in the year following adoption, as if the new standard was
adopted effective January 1, 2016, and accordingly, we have
reflected additional tax benefits of $5 for the three and six months
ended June 30, 2016 in our consolidated statement of operations.

ALEXION PHARMACEUTICALS, INC.

TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

(in millions, except per share amounts)

(unaudited)

Three months ended

Six months ended

June 30

June 30

2017

2016

2017

2016

GAAP net income

$

165

$

120

$

335

$

212

Before tax adjustments:

Cost of sales:

Share-based compensation

3

2

5

5

Fair value adjustment in inventory acquired

3

1

5

2

Research and development expense:

Share-based compensation

20

15

36

30

Upfront and milestone payments related to licenses and collaborations

—

—

9

3

Selling, general and administrative expense:

Share-based compensation

38

32

74

70

Amortization of purchased intangible assets

80

80

160

160

Change in fair value of contingent consideration

24

5

28

(10

)

Acquisition-related costs

—

1

—

2

Restructuring expenses (1)

3

—

27

1

Impairment of intangible assets (2)

31

—

31

—

Adjustments to income tax expense

(12

)

2

(39

)

10

Non-GAAP net income

$

355

$

258

$

671

$

485

GAAP earnings per common share - diluted

$

0.73

$

0.53

$

1.49

$

0.94

Non-GAAP earnings per common share - diluted

$

1.56

$

1.13

$

2.94

$

2.12

Shares used in computing diluted earnings per common share (GAAP)

225

226

225

226

Shares used in computing diluted earnings per common share (non-GAAP)

228

228

228

229

(1)

Restructuring expenses were $3 million and $27 million for the three
and six months ended June 30, 2017, respectively, related to the
company-wide restructuring initiated in the first quarter 2017.

(2)

In the second quarter 2017, we recognized an impairment charge of
$31 million, which fully impaired SBC-103, the acquired in-process
research and development asset, due to clinical trial results.

ALEXION PHARMACEUTICALS, INC.

TABLE 3: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL GUIDANCE

(in millions, except per share amounts and percentages)

(unaudited)

Twelve months ended

December 31, 2017

Low

High

GAAP net income

$

640

$

708

Before tax adjustments:

Share-based compensation

246

219

Fair value adjustment in inventory acquired

5

5

Upfront and milestone payments related to licenses and collaborations

10

9

Amortization of purchased intangible assets

320

320

Change in fair value of contingent consideration

36

36

Restructuring expenses

37

27

Impairment of intangible assets

31

31

Adjustments to income tax expense

(88

)

(84

)

Non-GAAP net income

$

1,237

$

1,271

Diluted GAAP earnings per common share

$

2.82

$

3.12

Diluted non-GAAP earnings per common share

$

5.40

$

5.55

Operating expense and margin (% total revenues)

GAAP research and development expense

25

%

23

%

Share-based compensation

(2

)%

(2

)%

Upfront and milestone payments related to licenses and collaborations

(1

)%

0

%

Non-GAAP research and development expense

22

%

21

%

GAAP selling, general and administrative expense

30

%

29

%

Share-based compensation

(4

)%

(4

)%

Non-GAAP selling, general and administrative expense

26

%

25

%

GAAP operating margin

23

%

26

%

Share-based compensation

7

%

6

%

Fair value adjustment in inventory acquired

0

%

0

%

Upfront and milestone payments related to licenses and collaborations

1

%

0

%

Amortization of purchased intangible assets

9

%

9

%

Change in fair value of contingent consideration

1

%

1

%

Restructuring expenses

1

%

1

%

Impairment of intangible assets

1

%

1

%

Non-GAAP operating margin

43

%

44

%

ALEXION PHARMACEUTICALS, INC.

TABLE 4: NET PRODUCT SALES BY GEOGRAPHY

(in millions)

(unaudited)

Three months ended

Six months ended

June 30

June 30

2017

2016

2017

2016

Soliris

United States

$

318

$

261

$

606

$

498

Europe

249

239

490

463

Asia Pacific

81

74

160

143

Rest of World

166

127

341

262

Total Soliris

$

814

$

701

$

1,597

$

1,366

Strensiq

United States

$

70

$

40

$

133

$

67

Europe

8

2

14

4

Asia Pacific

4

3

8

6

Rest of World

1

—

2

1

Total Strensiq

$

83

$

45

$

157

$

78

Kanuma

United States

$

11

$

5

$

20

$

6

Europe

3

2

5

3

Asia Pacific

1

—

1

—

Rest of World

—

—

1

—

Total Kanuma

$

15

$

7

$

27

$

9

Net Product Sales

United States

$

399

$

306

$

759

$

571

Europe

260

243

509

470

Asia Pacific

86

77

169

149

Rest of World

167

127

344

263

Total Net Product Sales

$

912

$

753

$

1,781

$

1,453

ALEXION PHARMACEUTICALS, INC.

TABLE 5: CONDENSED CONSOLIDATED BALANCE SHEETS

(in millions)

(unaudited)

June 30

December 31

2017

2016

Cash and cash equivalents

$

542

$

966

Marketable securities

902

327

Trade accounts receivable, net

710

650

Inventories

410

375

Prepaid expenses and other current assets (1)

225

260

Property, plant and equipment, net

1,233

1,036

Intangible assets, net

4,112

4,303

Goodwill

5,037

5,037

Other assets

318

299

Total assets

$

13,489

$

13,253

Accounts payable and accrued expenses

$

613

$

572

Deferred revenue

14

37

Current portion of long-term debt

167

167

Current portion of contingent consideration

25

24

Other current liabilities

37

23

Long-term debt, less current portion

2,804

2,888

Contingent consideration

156

129

Facility lease obligation

277

233

Deferred tax liabilities

387

396

Other liabilities

134

90

Total liabilities

4,614

4,559

Total stockholders' equity (1)

8,875

8,694

Total liabilities and stockholders' equity

$

13,489

$

13,253

(1)

In October 2016, the FASB issued a new income tax standard that
eliminates the exception for an intra-entity asset transfer other
than inventory. We elected to early adopt this standard in the first
quarter 2017. As a result of the adoption, we recorded a $19 million
decrease in retained earnings, primarily resulting from the
elimination of previously recorded prepaid tax assets.